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FDA 510(k)

SPECTRO-SUR SET

K-Number: K791315 · 1979-08-16

ApplicantHelena Laboratories
Decision Date1979-08-16
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPECTRO-SUR SET is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791315. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRO-SUR SET?

SPECTRO-SUR SET is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Helena Laboratories. The 510(k) number is K791315.

When did SPECTRO-SUR SET receive FDA 510(k) clearance?

SPECTRO-SUR SET received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791315.

Who is the listed applicant for SPECTRO-SUR SET?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRO-SUR SET?

The FDA product code for SPECTRO-SUR SET is JIS.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: JIS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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